NCT01151124

Brief Summary

The study is designed to test the safety of a manufactured neural stem cell line (CTX cells) delivered by injection into the damaged brains of male patients 60 years of age or over who remain moderately to severely disabled 6 months to 5 years following an ischemic stroke. In addition the trial will evaluate a range of potential efficacy measures for future trials. Treatment will involve a single injection of one of four doses of CTX cells into the patient's brain in a carefully controlled neurosurgical operation performed under general anesthetic. The trial is designed to treat 12 patients and measure outcomes over 24 months. Patients will be invited to participate in a long-term follow-up trial for a further 8 years.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
11

participants targeted

Target at below P25 for phase_1 stroke

Timeline
Completed

Started Jun 2010

Longer than P75 for phase_1 stroke

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

June 9, 2010

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 25, 2010

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
10 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2022

Completed
Last Updated

July 6, 2023

Status Verified

July 1, 2023

Enrollment Period

2.3 years

First QC Date

June 9, 2010

Last Update Submit

July 4, 2023

Conditions

Stroke

Outcome Measures

Primary Outcomes (1)

  • Incidence of adverse events

    AEs monitored include vital signs, C-reactive protein and full blood count, structural MRI to seek evidence of hemorrhage, new infarction, inflammation or tumor, NIHSS measure (changes greater than 4) to indicate clinically significant neurological deterioration, neurological examination, CTX0E03 antibody screen, changes to concomitant medications

    1 year

Secondary Outcomes (4)

  • Barthel Index

    1 year

  • Mini-Mental State Examination

    1 year

  • modified Rankin Score

    1 year

  • EQ-5D

    1 year

Study Arms (1)

CTX0E03 DP

EXPERIMENTAL

human neural stem cell product, once only injection, increasing doses

Biological: CTX0E03 neural stem cells

Interventions

CTX0E03 neural stem cellsBIOLOGICAL

Single administration by surgical delivery to the damaged area of the brain

CTX0E03 DP

Eligibility Criteria

Age60 Years - 85 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males
  • years or over
  • Unilateral ischemic stroke involving subcortical white matter or Basal Ganglia 6 months to 5 years before entry
  • NIHSS score minimum 6 with hemiparesis (2 or more for motor arm and leg)
  • Neurologically stable for 2 m
  • modified Rankin score of 2-4
  • Fit for general anesthesia, neurosurgery
  • Capacity to consent
  • Infarct at least 1cm diameter

You may not qualify if:

  • Structural brain vascular lesions requiring surgery or increasing the risk of stereotaxic implantation
  • Unstable medical conditions with expected survival \<12 months
  • Any medical condition that would impair participation (eg progressive neurological disorders, mental illness)
  • Major surgery within 30 days
  • Previous allogeneic tissue transplant
  • MMSE \< 24
  • Epilepsy
  • Coagulation disorders or anticoagulant treatment that cannot be interrupted
  • Stimulants, botox, tamoxifen
  • Contraindications to MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Division of Clinical Neurosciences, Glasgow Southern General Hospital

Glasgow, G51 4TF, United Kingdom

Location

Related Publications (4)

  • Kalladka D, Sinden J, Pollock K, Haig C, McLean J, Smith W, McConnachie A, Santosh C, Bath PM, Dunn L, Muir KW. Human neural stem cells in patients with chronic ischaemic stroke (PISCES): a phase 1, first-in-man study. Lancet. 2016 Aug 20;388(10046):787-96. doi: 10.1016/S0140-6736(16)30513-X. Epub 2016 Aug 3.

    PMID: 27497862DERIVED

  • Stevanato L, Thanabalasundaram L, Vysokov N, Sinden JD. Investigation of Content, Stoichiometry and Transfer of miRNA from Human Neural Stem Cell Line Derived Exosomes. PLoS One. 2016 Jan 11;11(1):e0146353. doi: 10.1371/journal.pone.0146353. eCollection 2016.

    PMID: 26752061DERIVED

  • Stevanato L, Hicks C, Sinden JD. Differentiation of a Human Neural Stem Cell Line on Three Dimensional Cultures, Analysis of MicroRNA and Putative Target Genes. J Vis Exp. 2015 Apr 12;(98):52410. doi: 10.3791/52410.

    PMID: 25938519DERIVED

  • Stevanato L, Sinden JD. The effects of microRNAs on human neural stem cell differentiation in two- and three-dimensional cultures. Stem Cell Res Ther. 2014 Apr 11;5(2):49. doi: 10.1186/scrt437.

    PMID: 24725992DERIVED

MeSH Terms

Conditions

Stroke

Condition Hierarchy (Ancestors)

Cerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 9, 2010

First Posted

June 25, 2010

Study Start

June 1, 2010

Primary Completion

October 1, 2012

Study Completion

October 1, 2022

Last Updated

July 6, 2023

Record last verified: 2023-07

Locations

GB(1)